ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS— 510(k) K011868

Substantially Equivalent

Debio Tech SA

FDA 510(k) clearance K011868 for ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS, Substantially Equivalent on 2001-09-04. Applicant: Debio Tech SA.

Clearance details

Applicant: Debio Tech SA
Product code: Code LZH
Advisory panel: General Hospital
Date received: 2001-06-14
Decision date: 2001-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZH

product code LZH

Death: 12
Malfunction: 4,186
Total: 4,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.